3.9 Effect of recombinant activated factor VII on outcomes

Currently, recombinant activated factor VII (rFVIIa) is approved in Australia and New Zealand for the control of bleeding and prophylaxis for surgery in patients with inhibitors to coagulation factors FVIII or FIX, congenital factor VII deficiency and Glanzmann’s thrombasthenia (with glycoprotein IIb-IIIa, and/or antibodies to human leukocyte antigen plus refractoriness to platelet infusion). Any use outside of these indications is considered ‘off-licence’.

Three systematic reviews (one of which was Level I and of good quality) were identified that investigated the clinical effectiveness of rFVIIa as either prophylaxis or treatment to manage bleeding in the perioperative setting.262-264 Two reviews presented evidence pertaining only to cardiac surgery,263,264 and one presented evidence from studies on a range of surgery types,262 including prostatectomy, liver transplantation, orthopaedic surgery and cardiac surgery.

Another seven Level II studies (of poor to fair quality) were identified, of which three presented evidence pertaining to cardiac surgery,265–267 and four presented evidence on a range of surgical procedures.249,268-270

EVIDENCE STATEMENTS – effect of blood components	Evidence	Consistency	Clinical impact	Generalisability	Applicability
In surgical patients, there is insufficient evidence to determine the effect of prophylactic or therapeutic use of rFVIIa on mortality.			X
In surgical patients, there is insufficient evidence to determine the effect of prophylactic or therapeutic use of rFVIIa on the risk of thrombotic adverse events.			X
In surgical patients, the prophylactic or therapeutic use of rFVIIa may reduce the incidence of transfusion.
In cardiac surgery patients, the prophylactic or therapeutic use of rFVIIa may reduce the likelihood of re-operation.
In surgical patients, the prophylactic or therapeutic use of rFVIIa reduces blood loss.
In surgical patients, there is insufficient evidence to determine the impact of prophylactic or therapeutic use of rFVIIa on hospital or ICU length of stay.			X

ICU, intensive care unit; rFVIIa, recombinant activated factor VII

(See Table 2.2)

RECOMMENDATION – use of recombinant factor VIIa

R22 GRADE C	The prophylactic or routine therapeutic use of rFVIIa is not recommended because concerns remain about its safety profile, particularly in relation to thrombotic adverse events (Grade C).

PRACTICE POINT – use of recombinant factor VIIa

PP20	The administration of rFVIIa may be considered in the perioperative patient with life-threatening haemorrhage after conventional measures, including surgical haemostasis, use of antifibrinolytics and appropriate blood component therapy have failed.

rFVIIa, recombinant activated factor VII